FITBIR Data Sharing Schedule
Six months after submission of the data, the Core (required) and Basic (recommended) TBI common data elements (CDEs) that are used in the study are expected to be made available to all qualified and approved researchers (Recipients) as determined by the Data Access and Quality Committee (DAQC). Other data fields can also be made available at the submitting program director/principal investigator’s (PD/PI's), i.e. Submitter’s, discretion. Outcomes data and other data elements needed by the PD/PI to test his/her hypotheses or research questions, referred to as Experimental Data, will be made available in a staged manner. Six months after the award period ends, Experimental Data will be open to other researchers who have submitted data to FITBIR (Submitters). Twelve months after the award period ends, Experimental Data will be open to all qualified and approved researchers (Recipients).

Table. Summary of the FITBIR Data Sharing Schedule

Core and Basic CDEs

Data are uploaded quarterly after subject enrollment begins and data are available six months after submission to all approved FITBIR Data Recipients. Specific CDEs can be exempted pending approval by the DAQC if they are needed to test the primary study hypothesis or research question.

Experimental Data

All approved FITBIR Data Recipients gain access either:
Six months after the award period ends if they are a FITBIR Submitter; or
Twelve months after the award period ends for those who are not FITBIR Submitters.

Access can also be granted earlier if agreed to by the Submitters of ongoing study(s) or in rare cases when the DAQC over rules the Submitters’ denial on the grounds that the request does not compromise completion of the ongoing study.

Investigators are also strongly encouraged to collaborate and share data throughout the study to accelerate research and advance knowledge on TBI. To facilitate collaboration, data access request forms may be submitted before the award period ends to the DAQC for initial review and then forwarded on to the relevant Submitters. The Submitters may choose to collaborate and/or to provide access to all or some of their Experimental Data, in which case the data will be made available to the data Recipients. Alternatively, the Submitters may choose to deny early access, in which case the request will be reviewed by the DAQC in consultation with the Submitters. In this case, approvals for early access will only be granted by the DACQ if it is clear that the data request does not negatively impact the completion of the original study. For example, prospective data collection projects that are powered to answer specific questions would be jeopardized by premature analysis of these same questions. However, if important research can be accomplished without jeopardizing the study, the value of the FITBIR data will be greatly enhanced by data sharing that advances the science of TBI.